WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Diseases
- Sponsor
- Tilburg University
- Enrollment
- 350
- Locations
- 6
- Primary Endpoint
- Anxiety
- Last Updated
- 13 years ago
Overview
Brief Summary
The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet.
The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.
Investigators
Dr. SS Pedersen
Professor of cardiac psychology
Tilburg University
Eligibility Criteria
Inclusion Criteria
- •patients implanted with a cardioverter-defibrillator (ICD)
- •between 18-75 years of age
- •speaking and understanding Dutch
- •with access to the internet and ability to use the internet
- •providing written informed consent
Exclusion Criteria
- •a life expectancy less than 1 year
- •a history of psychiatric illness other than affective/anxiety disorders
- •on the waiting list for heart transplantation
- •with insufficient knowledge of the Dutch language
Outcomes
Primary Outcomes
Anxiety
Time Frame: 52 weeks
Anxiet
Time Frame: 26 weeks
Secondary Outcomes
- Cortisol awakening response(52 weeks)